The TOPAZ Mobile DR System, (TOPAZ), is a mobile x-ray system and is a modification of the predicate device. There are 2 models for TOPAZ: TOPAZ-32D (32KW) and TOPAZ-40D (40KW). TOPAZ, may be moved quietly and smoothly with a motor drive mechanism.

The core part of x-ray source is a tube assembly, motorized x-ray collimator, HV cable assembly and high frequency x-ray generator. A touch screen LCD based x-ray control console provides a user-friendly interface and technique selection. The Collimator supports high accuracy for selected x-ray field size over any SID. Selection of an anatomical study on the imaging software automatically sets up the x-ray generator's pre-programmed exposure technique.

The X-ray passing through a patient's body is sent to the detector and then converted into electrical signals. These signals go through the process of amplification and digital data conversion in the signal process on the workstation and saved in a DICOM file for review on the device or on a Picture Archiving & Communication System (PACS) workstation.

AI/ML Overview

The provided text is a 510(k) summary for the DRGEM TOPAZ Mobile DR System. It discusses the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain any information about a study that proves the device meets specific acceptance criteria related to a human-in-the-loop or standalone AI performance study.

The "PERFORMANCE DATA" section explicitly states that "Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met." This refers to engineering and safety testing against recognized standards (e.g., IEC 60601-2-54, ANSI AAMI ES60601-1, IEC 62304 for software), not clinical performance studies involving AI or human readers.

The key information missing to answer your request is data from a clinical performance study (e.g., diagnostic accuracy, reader study results). The device described is a mobile X-ray imaging system, which captures images. There is no mention of any integrated AI component that would require an AI-specific performance study with acceptance criteria for diagnostic performance.

Therefore, I cannot populate the table or answer most of your questions as the necessary information is not present in the provided document.

Here's what can be inferred or stated based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot populate. The document focuses on regulatory compliance and engineering standards for the X-ray system itself, not diagnostic performance metrics (e.g., sensitivity, specificity, AUC) for an AI component. The "acceptance criteria" mentioned are for non-clinical engineering and safety tests, not clinical performance.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/Not mentioned for clinical performance. The "test set" referenced in the document pertains to engineering validation and verification tests of the X-ray system's functions, not a clinical data set for evaluating diagnostic performance of an AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not mentioned. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic performance studies. This document reports on non-clinical engineering tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not mentioned. Adjudication methods are used in reader studies or for ground truth establishment in clinical performance. This document does not describe such studies.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document does not describe any MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. The document does not describe any standalone algorithm performance testing related to diagnostic accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable/Not mentioned for clinical performance. For engineering tests, the "ground truth" would be the successful operation of the device according to its specifications and regulatory standards.

8. The sample size for the training set

Not applicable/Not mentioned. This information would be relevant for an AI device. The document describes an X-ray imaging system, not an AI.

9. How the ground truth for the training set was established

Not applicable/Not mentioned. This information would be relevant for an AI device. The document describes an X-ray imaging system, not an AI.

Summary of the Device and its Testing as per the document:

The TOPAZ Mobile DR System is a mobile X-ray imaging system. The 510(k) submission primarily focuses on demonstrating its substantial equivalence to an existing predicate device (K183292, also a TOPAZ Mobile DR System from DRGEM). The main difference for this new 510(k) (K201124) is the addition of five previously cleared digital X-ray detectors to the TOPAZ system.

The "Performance Data" section details that the system underwent non-clinical testing against various recognized international and national standards (e.g., IEC 60601 series for medical electrical equipment safety, radiation protection, usability; IEC 62304 for medical device software; DICOM standards, JPEG standards, etc.). The acceptance criteria for these tests were met, demonstrating the device's safety and effectiveness as an X-ray imaging system, and its performance as well as the predicate device. This refers to the engineering and regulatory compliance of the hardware and integrated software for image acquisition and handling, not the diagnostic interpretation or AI assistance.

Summary

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May 19, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

DRGEM Corporation % Mr. Carl Alletto Consultant OTech, Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K201124

Trade/Device Name: TOPAZ Mobile DR System Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: April 24, 2020 Received: April 27, 2020

Dear Mr. Alletto:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201124

Device Name TOPAZ Mobile DR System

Indications for Use (Describe)

The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy.

This device is not intended for mammography, bone density, fluoroscopy and angiography applications.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary of Safety K201124

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: May 14, 2020

I. SUBMITTER

DRGEM Corporation 7F E-B/D Gwangmyeong Techno-Park 60, Haan-ro, Gwangmyeong-si, Gyeonggi-do, 14322 Korea Email: radcheck@drgem.co.kr

Contact Person: Mr. Ki-Nam YANG, Director | QM representative

II. DEVICE

Name of Device:	TOPAZ Mobile DR System
Common or Usual Name:	Mobile x-ray system
Regulation Name:	Mobile x-ray system
Regulation:	21 CFR 892.1720
Product Code:	IZL
Regulatory Class:	II

III. PREDICATE DEVICE

The TOPAZ Mobile DR System device is substantially equivalent to:

Device Classification Name	Mobile X-Ray System
510(K) Number	K183292
Device Name	Topaz Mobile DR System
Applicant	DRGEM Corporation7F E-B/D Gwangmyeong Techno-Park 60, Haan-RoGwangmyeong-Si, KR 14322
Regulation Number	892.1720
Classification Product Code	IZL
Decision Date	05/15/2019
Regulation Medical Specialty	Radiology

IV. DEVICE DESCRIPTION

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510(k) Summary of Safety

PacScan4336W V4 which was cleared as part of the Nexus DR™ Digital X-ray Imaging System (with PaxScan 4336Wv4). K161459. The modified device can use five additional digital detectors which also have been previously cleared by 510(k): XRpad2 3025 HWC -K161942, XRpad2 4336 HWC - K161966, XRpad2 4343 HWC - K181526, Mano4343W -K183713, and Mano4336W - K182551.

The TOPAZ Workstation Image Management features and functions are as follows in both the predicate and modified device:

. ROI: Default 13 ROI support
MARK: Unlimited support (User preset support) ●
. Horizontal Flip
Vertical Flip .
Rotate Clockwise (CW) ●
Rotate Counter Clockwise (CCW) ●
. Inverse (Black or White)
. Text Annotation
Caliper / Ruler: Distance tool ●
. Angle: Angle measurement tool
. Zoom: Image zoom in/out
. Maqnify: Image magnify glass window
. Pan: Image panning

V. INDICATIONS FOR USE

The TOPAZ Mobile DR System, is a mobile X-ray imaging system, for the purpose of acquiring X-ray images of the desired parts of a patient's anatomy. This device is not intended for mammography, bone density, fluoroscopy and angiography applications.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

TOPAZ Mobile DR System is a mobile x-ray system.

Summary of differences:

The difference between the predicate device and the modified device is the addition of five previously cleared x-ray detectors to the TOPAZ system. The added detectors are:

. XRpad2 3025 HWC - 510(k) number K161942
XRpad2 4336 HWC 510(k) number K161966 .
. XRpad2 4343 HWC – 510(k) number K181526
Mano4343W – 510(k) number K183713
. Mano4336W – 510(k) number K182551

VII. PERFORMANCE DATA

Nonclinical Testing:

The complete system has been assessed and tested at the factory and by Standards testing facilities. The TOPAZ Mobile DR System has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate all input functions, output functions, and actions performed by TOPAZ, and followed the process documented in the System Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

The following Standards were used to test the system and TOPAZ Mobile DR System, has met all the requirements listed in the Standards except for inapplicable requirements (which are listed in the various test reports):

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IEC 60601-2-54 Ed. 1.0:2009, Medical electrical equipment Part 2-54: Particular requirements o for the basic safety and essential performance of X-ray equipment for radiography and radioscopy (including Technical Corrigendum 1: 2010 and Technical Corrigendum 2:2011) FDA Recognized Standard #12-296.
ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 O (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). FDA Recognized Standard #19-4.
o IEC 60601-1-6 Edition 3.1 2013-10, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability. FDA Recognized Standard #5-89.
IEC 60601-1-3 Edition 2.1 2013-04, Medical electrical equipment Part 1-3: General o requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment. FDA Recognized Standard #12-269.
IEC 60601-2-28 Edition 2.0 2010-03. Medical electrical equipment Part 2-28: Particular O requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis. Recognized Standard #12-204.
ANSI AAMI IEC 62304:2006. Medical device software Software life cvcle processes. FDA o Recognized Standard #13-32.
IEC 60601-1-2 Edition 4.0 2014-02. Medical electrical equipment Part 1-2: General O requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances Requirements and tests. FDA Recognized Standard #19-8.
o NEMA PS 3.1 - 3.20 (2016). Digital Imaging and Communications in Medicine (DICOM) Set DICOM Standard. FDA Recognized Standard #12-300.
JPEG Standard IEC/ISO10918-1 First edition 1994-02-15, Information technology Digital O compression and coding of continuous-tone still images: Requirements and guidelines [Including: Technical Corrigendum 1 (2005)]. FDA Recognized Standard #12-261.
IEC 62494-1 Edition 1.0 (2008-08). Medical electrical equipment Exposure index of digital Xo ray imaging systems - Part 1: Definitions and requirements for general radiography. FDA Recognized Standard #12-215.
ANSI AAMI ISO 14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices o Applications of risk management to medical devices. FDA Recognized Standard #05-40.
ISO 15223-1 Third Edition 2016-11-01, Medical devices Symbols to be used with medical O device labels, labelling, and information to be supplied - Part 1: General requirements. FDA Recognized Standard #05-117.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the TOPAZ Mobile DR System, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The subject device will be manufactured in accordance with the voluntary standards listed in the voluntary standard survey. The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device.

Therefore, the TOPAZ Mobile DR System, is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.